1. Field of the Invention
This invention pertains to packaging which can be used for handling, storage, and shipping of medical diagnostic samples. In particular, the invention relates to sample trays which have universal configurations, enabling them to hold a variety of shapes and sizes of sampling devices and vessels, and which trays are light weight and tough (exhibit good mechanical strength). The universal sample trays may be used individually, or may be placed within a pouch which is designed to reduce or eliminate the flow of any liquid from the tray into the surrounding environment. A universal tray inside a pouch makes an excellent shipping package for medical diagnostic samples.
2. Background of the Invention
Today's medical industry generates millions, if not billions, of samples taken for diagnostic purposes. Examples of such samples include urine, blood and tissue samples. These diagnostic samples are commonly drawn through needles and placed in tubes, or on slides (for example), for purposes of handling. Frequently the analysis of the diagnostic sample is not carried out at the clinic at which the sample was taken, but the sample is shipped to a laboratory which specializes in analysis of the particular kind of sample. Whether the sample is stored temporarily until analysis can be done at the clinic at which the sample was taken, or whether the sample is shipped to an outside laboratory for analysis, the sample must be stored, and in the latter case shipped, in a convenient manner.
Patent application Ser. No. 07/278,585 and its continuation Ser. No. 534,725 owned by the present applicants, and hereby incorporated by reference, discloses specialized packaging for shipment and containment of hazardous liquids, including medical diagnostic samples which may contain etiologic agents. This specialized packaging comprises a bag or pouch in which at least one container of liquid can be sealed so that the package completely surrounds and isolates the container of liquid. The bag or pouch comprises at least two layers, including an interior layer and an exterior layer. The interior layer of the bag or pouch is adjacent to the container and can be penetrated or permeated by liquid which escapes from the container, but the exterior layer of the pouch, which is in contact with the external ambient environment, is impermeable by the liquid or hazardous vapors thereof. One of the critical features of the bag or pouch is that it has a means for sealing the bag or pouch after the sample/container of liquid is placed inside, wherein the seal is impermeable by the liquid or vapors thereof. The pouch or bag can have numerous other features such as, for example, a layer capable of immobilizing liquid; a reactant present which deactivates or destroys an etiologic agent; and a liquid indicating means, whereby a visual indication that liquid is in direct contact with the pouch interior is automatically and continually provided at a location which can be observed from the exterior of the pouch.
It is known in the art to use styrofoam trays into which sample needles, tubes and slides are placed during sample kit assembly, for subsequent handling by medical personnel. The styrofoam tray can be placed in a shipping box, envelope or cylinder, to hold the samples in place within such container. However, in shipping samples such as tubes of blood, frequently the tubes break due to rough package handling, causing blood to leak out the edges of the styrofoam tray or cracks or breaks in the tray. Styrofoam trays are not known for their mechanical strength. Although a bag or pouch of the type described in patent application Ser. No. 07/278,585 can be used to prevent leakage of a liquid sample from the sample tray during shipment, and can help prevent breakage of the diagnostic sample container, there is a need for an improved sample tray which can be used during handling, storage and shipment of the diagnostic samples. Such a tray must be light weight, tough, and very importantly, inexpensive to manufacture. It is also preferred that the tray manufacturing process not be environmentally detrimental. For example, the blowing agents used to generate styrofoam are detrimental to the earth's ozone layer.
Some of the kinds of packaging presently known for shipment of hazardous liquids in general (but not particularly for the handling, shipping and storage of biological, diagnostic samples, as will be evident to one skilled in the art) are described below. Also described are diagnostic packaging systems presently known to the applicants in addition to the commonly used styrofoam trays described above.
U.S. Pat. No. 4,756,937 to Mentzer, issued July 12, 1988 describes a protective wrapping, barrier shield, receptacle, and/or liner in the packaging of a container or containers of hazardous chemical. These materials are demonstrated as layered structures, wherein at least one of the layers comprises a shock absorbing structure, and another of the layers is a porous structure which has been conditioned to react with the hazardous chemical. The multilayered structure can be formed into the configuration of a cup-like receptacle.
U.S. Pat. No. 4,573,578 to Greminger, Jr. et al., issued Mar. 4, 1986, discloses safety packages prepared for transportation of methanol, wherein ethyl cellulose having from about 45 to 46.5 weight percent substitution is employed as a sorbent. The drawings. at FIG. 1 show a multilayered bag comprising the sorbent, surrounding a jar or bottle which contains the methanol. The bag is tied at the top with a cord.
U.S. Pat. No. 4,706,996 to Fasham, issued Nov. 17, 1987, describes a hospital form set with detachable bag. This invention is concerned with a business form assembly for use in hospitals and capable of recording details of a medical test, for example, a blood test. The assembly comprises a forms sheet and a bag capable of receiving a container containing a test sample and having closure means at the mouth of the bag to secure the container in the bag. The bag is secured to the forms sheet by an adhesive. The drawings, at FIG. 3, show a single tube-shaped container inside a bag, with the bag secured to the forms set. The bag appears to be a clear or at least transparent plastic bag having rib and channel parts at one end which can be used to close the bag. The bag is not designed to protect the sample's tube-shaped container, as is evidenced not only by the drawings and general description of the assembly, but also by the fact that a drip tray is placed under the rack upon which the hospital form set with sample attached can be transported and stored. The system is designed especially to keep the data information form attached to a bag in which a single sample is placed, for handling within a hospital or clinic. This type of assembly is not useful in shipping samples to an outside testing/analysis lab, since each bag is designed to hold only one sample and provides no significant protection for the sample container.
U.S. Pat. No. 4,637,061 to Riese, issued Jan. 13, 1989, describes a specimen, sample collection and transport container. The specimen, sample collection and transport container comprises a flexible plastic bag which is separated into selectively sealed chambers by leakproof interlocking multiple track, reclosable fasteners. The bag comprises a sheet of coextruded polyethylene-Saran-polyethylene material which is folded in half and sealed at the side edges. An interior fastener substantially traverses the container parallel to the folded bottom, thereby defining a lower chamber. An entrance fastener is affixed to the upper edges to selectively seal the entrance. Gripper flaps are added to the exterior of the container to facilitate the opening of the interior fastener. The lower chamber is supplied with a fixative or transport solution which is introduced by clipping or puncturing the lower corner or edge of the bag. The corner or hole is then sealed.
U.S. Pat. No. 2,987,174 to A.H. Free et al, issued June 6, 1961, discloses a test sample container for collecting biological fluids such as urine, blood and the like for preservation during storage and transportation by mail and similar means to a laboratory where the specimens may be readily tested for the determination of the presence of various materials for diagnostic and therapeutic purposes. The claimed device is a device for collecting and transporting a urine sample, the device comprising a front sheet and a back sheet, each sheet having an inner and outer face and being joined along a common edge to form a folder which, in closed position, places the inner face of a front sheet in closely contiguous position with an inner face of a back sheet. A layer of moisture absorbent material is present on the inner face of both the front and back sheet. A section of bibulous urine sample absorbing material is affixed to one edge of the folder and is foldable into the opened folder between the non-wettable porous screens, out of direct contact with the layers of absorbent material. A deposit of urine preservative material is present on the bibulous material to stabilize the urine sample.
None of the sample containers or trays described above provides the functional, light-weight, tough sample tray of the kind needed by the medical industry today.